tetanus and reduced diphtheria toxoids/ acellular pertussis vaccine (Adacel, Boostrix, Tdap)

Dosing and uses of Adacel, Boostrix (tetanus and reduced diphtheria toxoids/ acellular pertussis vaccine)

• Adult
• Pediatric

 

Adult dosage forms and strengths

Lf = limits of flocculation

pertussis/diphtheria/tetanus

tdap suspension

• (15.5mcg/2Lf/5Lf)/0.5mL (Adacel)
• (18.5mcg/2.5Lf/5Lf)/0.5mL (Boostrix)

 

Immunization

Indicated for active booster immunization against tetanus, diphtheria, and pertussis as a single dose; substitute 1-time dose of Tdap for Td booster, then boost with Td every 10 yr

0.5 mL IM once

Boostrix: Approved for individuals aged ≥10 yr including those aged ≥65 yr

Adacel: Approved for individuals aged 10 through 64 yr

CDC ACIP Recommendations

• CDC recommends that all adults aged 65 yr or older who have not previously received Tdap should receive 1 Tdap booster dose in place of Td (ACIP; February 2012)
• Indicated for adults (including those aged 65 yr or older) who have not previously received Tdap and who have or who anticipate having close contact with infants younger than 12 months of age (eg, parents, grandparents, childcare providers, healthcare workers); from ACIP revised recommendations MMWR January 14, 2011 / 60(01);13-15
• Also indicated for healthcare personnel, regardless of age, in hospitals or ambulatory care settings who have direct patient contact and have not previously received Tdap; ACIP revised recommendations for healthcare personnel February 23, 2011 (Fall 2011 scheduled publication in MMWR)

 

Immunization During Pregnancy

Administer Tdap vaccine to pregnant women to reduce morbidity and mortality associated with pertussis in infants younger than 2 months

The CDC's Advisory Committee on Immunization Practices (ACIP) recommends all pregnant women receive 1 dose of Tdap during each pregnancy ideally between 27 and 36 weeks of gestation regardless of vaccination history and time since prior Td or Tdap

 

Administration

Administer in deltoid muscle

At least 5 yr should have elapsed since last dose of DTP containing vaccine, except during pregnancy

 

Pediatric dosage forms and strengths

tdap suspension

• (15.5mcg/2Lf/5Lf)/0.5mL (Adacel)
• (18.5mcg/2.5Lf/5Lf)/0.5mL (Boostrix)

 

Routine Vaccination

Indicated as active booster immunization for prevention of tetanus, diphtheria (not indicated for primary immunization series)

0.5 mL IM once as a single one-time Tdap dose (do not repeat Tdap) ideally at age 11-12 yr

For children aged 7-10 years who are not fully immunized with the childhood DTaP series, Tdap should be substituted for a single dose of Td vaccine in the catch-up series

Boostrix: Approved for individuals aged ≥10 yr including those aged ≥65 yr

Adacel: Approved for individuals aged 10 through 64 yr

Pregnancy: Administer 1 dose of Tdap vaccine to pregnant adolescents during each pregnancy (preferred between 27 through 36 weeks of gestation) regardless of time since prior Td or Tdap vaccination

Refer to https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf

 

Catch-up Vaccination

Persons aged ≥7 years who are not fully immunized with DTaP vaccine should receive Tdap vaccine as 1 (preferably the first) dose in the catch-up series; if additional doses are needed, use Td vaccine

For children 7 through 10 years who receive a dose of Tdap as part of the catch-up series, an adolescent Tdap vaccine dose at age 11 through 12 years should NOT be administered

Td should be administered instead 10 yr after the Tdap dose

Persons aged 11 through 18 yr who have not received Tdap vaccine should receive a dose followed by tetanus and diphtheria toxoids (Td) booster doses every 10 yr thereafter

Inadvertent doses of DTaP vaccine

• If administered inadvertently to a child aged 7 through 10 yr, may count as part of the catch-up series; this dose may count as the adolescent Tdap dose, or the child can later receive a Tdap booster dose at age 11 through 12 yr
• If administered inadvertently to an adolescent aged 11 through 18 yr, the dose should be counted as the adolescent Tdap booster

 

Adacel, Boostrix (tetanus and reduced diphtheria toxoids/ acellular pertussis vaccine) adverse (side) effects

>10%

Moderate injection site reactions (15.1-18%)

Headache (2-14.2%)

 

1-10%

Body aches/muscle weakness (1.2-8.5%)

Injection site erythema (2.7-8.4%)

Injection site swelling (2.8-6.4%)

Fever (1.4-5%)

Chills, moderate (1.3-3.2%)

Nausea (1-3.2%)

Rash (2-2.7%)

Joint pain, moderate (2.5%)

Diarrhea (1.9-2.2%)

Severe injection site reactions (1.1-1.5%)

Vomiting (1-1.2%)

Lymphadenopathy (1%)

 

Warnings

Contraindications

Hypersensitivity

Encephalopathy with 7 days of previously administered pertussis antigen

History of Arthus reaction to prior tetanus vaccination (unless 10 yr have elapsed)

 

Cautions

Not indicated for primary vaccination series; for children aged 6 months to 7 yr, see DTap

Caution if Guillain-Barré syndrome and brachial neuritis has occurred with previously administered tetanus toxoid

Caution with neurologic disorders (eg, epilepsy, CVA, encephalopathic condition)

Defer vaccine if moderate or severe illness present

Attenuated immune response may occur with immunosuppressed conditions (eg, high-dose corticosteroids, use of antineoplastic agents, immunosuppressive illness)

Boostrix needleless prefilled syringes contain natural latex rubber

Epinephrine and other emergency equipment should be available to respond to hypersensitivity reactions

 

Pregnancy and lactation

Pregnancy category: C; May administer at end of 2nd trimester, or in 3rd trimester (ie, >20 weeks gestation)

Lactation: Unknown whether distributed in breast milk; however, according to the CDC, neither inactivated nor live vaccines administered to breastfeeding women affect maternal/infant safety

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Adacel, Boostrix (tetanus and reduced diphtheria toxoids/ acellular pertussis vaccine)

Mechanism of action

Active immunization resulting in development of neutralizing antibodies to tetanus, diphtheria, and pertussis toxins

These products convey active immunity via stimulation of production of endogenously produced antibodies

 

Pharmacokinetics

The onset of protection from disease is relatively slow, but duration is long lasting (years)

Duration: Variable, possibly >10 yr; Tdap maternal pertussis antibodies appear to wane greatly between subsequent pregnancies